Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)

• Registration Number: NCT01301703
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

Brief Summary

Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.

Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls

Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study First Submitted: 2011-02-21
• Study First Submitted QC: 2011-02-22
• Last Update Submitted: 2011-02-22
• Study First Posted: 2011-02-23
• Last Update Posted: 2011-02-23
• Study Start: 2011-03
• Primary Completion: 2011-12
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients suffering from RA
• Aged 18 to 64 years old

Exclusion Criteria

• Active disease requiring a change in drug regimen
• Known allergy to vaccine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tdap vaccination	Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)	Patients and controls will be vaccinated with BOOSTRIX (Tdap vaccine)

Primary Outcome Measures

Name	Time	Method
Immunogenicity of Tdap in patients suffering from rheumatoid arthritis	4-6 weeks after vaccination	Geometric mean titers and individual responses to components of pertussis, tetanus and diphtheria

Secondary Outcome Measures

Name	Time	Method
Safety of Tdap vaccine in RA patients	4-6 weeks after vaccination	Safety will be evaluated using the disease activity score (DAS) at baseline and 4-6 weeks later

Trial Locations

Locations (1)

Department of Rheumatology, Tel Aviv Medical Center; 🇮🇱 Tel Aviv, Israel